Statement of the Hon. Gerald J. Mossinghoff Presented to the Conference on Intellectual Property Implications of the Human Genome Project, Washington University School of Law

Apr 2002

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Statement of

Hon. Gerald J. Mossinghoff

Senior Counsel

Oblon, Spivak, McClelland, Maier & Neustadt

to the

Conference on Intellectual Property

Implications of the Human Genome Project

Center for Interdisciplinary Studies

Washington University School of Law

St. Louis, Missouri

April 12 & 13, 2002

Distinguished Guests, Ladies & Gentlemen:

I am honored to be asked to participate in this important conference on the intellectual properity implications of the human genome project. Honored — and thoroughly overwhelmed. As I told Scott Kieff when he extended his thoughtful invitation to me, I managed to get a high school education — from both the Jesuits and the Brothers of Mary here in St. Louis — a degree in electrical engineering from the Jesuits — at that other university in St. Louis — and a law degree: all without taking even an elementary course in biology. My advantage today, of course, is that I bring to this conference an uneducated layman's view of the subject.

When I went to St. Louis University, every graduate — even those in engineering — in effect had to get a minor in philosophy — which in those days was fairly well limited to studying the works of St. Thomas Aquinas. As I was preparing for this conference, I initially thought that a Thomastic approach to the patenting of parts of the human genome might prove to be helpful. At least in the popular press, it was directly related to the patenting of God's work, slavery, abortion, stem-cell research and animal and human cloning. I would add parenthetically, one article on the subject advised those involved in the debate to "Keep Their Genes On!"

But Mrs. Mossinghoff did not raise any courageous sons here in St. Louis, so I decided not to delve into these areas, leaving to others more qualified than I to address them. Instead today, I will address the key patent law elements in the debate regarding gene-related inventions:

Patentable subject matter;

Utility;

Enablement and Written Description; and

Novelty and Nonobviousness.

Are Gene-Related Inventions Patentable Subject Matter?

The answer is yes, without question. This answer would have been different a little over two decades ago when the United States Patent and Trademark Office under the Carter Administration opposed the grant of a patent on Dr. Ananda M. Chakrabarty's petroleum-eating enzyme. People can say what they will about the landmark Diamond v. Chakrabarty[1] case, but no one can seriously doubt that it led directly to the preeminence of the United States in biotechnology.

An interesting footnote to that case was the role played by the Upjohn Pharmaceutical Company in its outcome. Two cases involving patent applications involving living organisms were making their way though the United States Patent & Trademark Office ("USPTO") and the courts: Chakrabarty and In re Bergy. The Bergy application was owned by Upjohn and concerned a purified version of an antibiotic producing strain of streptomycin, a substance that appeared in nature but in an unpurified state. The purified version was invented by Dr. Malcolm E. Bergy. The USPTO Board of Appeals denied both applications based on the fact that the inventions involved living things. The Court of Customs and Patent Appeals ("CCPA"), predecessor of the present Court of Appeals for the Federal Circuit, ruled three-to-two that the patents should be granted because nothing in the patent laws barred the issuance of a patent to an otherwise patentable invention simply because it was alive.[2] The late Judge Giles E. Rich wrote the opinion for the majority of the CCPA, an opinion that ultimately had far-reaching implications.

The favorable ruling by the CCPA prompted the USPTO to appeal both Bergy and Chakrabarty to the Supreme Court. Both cases were sent back to the CCPA for reconsideration in light of the Supreme Court's opinion on mathematical algorithms in Parker v. Flook.[3] In early 1979, Judge Rich, again speaking on behalf of the majority of the CCPA, in Bergy and Chakrabarty, emphasized that biological conversions mediated by microorganisms are basically an application of basic chemistry and nothing in Parker v. Flook changed that opinion.

That second opinion of the CCPA was again appealed to the Supreme Court by the Carter Administration, with then-Patent Commissioner Sidney Diamond being named as Appellant. Meanwhile, Upjohn was persuaded to cancel its product claims covering the streptomycin producing the antibiotic lyncomycin. The thought prevalent among the patent bar was that it was far more likely that the Supreme Court would uphold the patenting of a modified living microorganism that did not occur in nature rather than one that did appear in nature but in a less purified form. In my view, that action by Upjohn, while perhaps not determinative, gave the five-to-four majority in Chakrabarty an uncluttered landscape on which to base their opinion.

Quite properly, the USPTO did interpret and continues to interpret Chakrabarty to require the patenting of living things whether they are genetically modified — like Dr. Chakrabarty's enzyme — or isolated and purified by the "hand of man" — like Dr. Bergy's streptomycin. This broad and proper reading of Chakrabarty, of course, plays directly into the decision to grant more than 1,000 patents on gene-related inventions and the hundreds of utility patents on genetically modified plants and animals.

As recently as this past December, the Supreme Court upheld utility patents on genetically-enhanced plants, relying upon its decision in Chakrabarty — this time in a six-to-two opinion. In J.E.M. Ag Supply v. Pioneer Hi-Bred International,[4] Justice Thomas stated:

As this Court recognized over 20 years ago in Chakrabarty, 447 U.S. at 308, the language of [35 U.S.C.] § 101 is extremely broad. 'In choosing such expansive terms as 'manufacture' and 'composition of matter,' modified by the comprehensive 'any,' Congress plainly contemplated that the patent laws would be given wide scope.' Ibid. This Court thus concluded in Chakrabarty that living things were patentable under § 101, and held that a man-made microorganism fell within the scope of the statute. As Congress recognized, 'the relevant distinction was not between living and inanimate things, but between products of nature, whether living or not, and human-made inventions.' Id., At 313.

I would predict that that same line of reasoning would lead at least the J.E.M. majority to uphold patents on gene-related inventions when that issue comes before the Supreme Court — as I predict it will.

Utility of Gene-Related Inventions

For a person to be entitled to a patent, he or she must invent or discover something that is "new and useful." That single word "useful" has led to a whole body of case law.

Specific Guidelines for Determining Utility of Gene-Related Inventions were issued on January 5, 2001.[5] In brief outline, they change the "old" two-pronged test of Specific and Credible utility to a three-pronged test that adds Substantial utility to the other two.

Stated in English, examiners are instructed to:

Review the claims and the supporting written description to determine if the applicant has asserted for the claimed invention any specific and substantial utility that is credible:

(a) If the applicant has asserted that the claimed invention is useful for any particular practical purpose (i.e., it has a 'specific and substantial utility') and the assertion would be considered credible by a person of ordinary skill in the art, do not impose a rejection based on lack of utility.

(1) A claimed invention must have a specific and substantial utility. This requirement excludes 'throw-away,' 'substantial,' or 'nonspecific' utilities, such as the use of a complex invention as landfill, as a way of satisfying the utility requirement of 35 U.S.C. 101.

(2) Credibility is assessed from the perspective of one of ordinary skill in the art in view of the disclosure and any other evidence of record (e.g., test data, affidavits or declarations from experts in the art, patents or printed publications) that is probative of the applicant's assertions. An applicant need only provide one credible assertion of specific and substantial utility for each claimed invention to satisfy the utility requirement.

(b) If no assertion of specific and substantial utility for the claimed invention made by the applicant is credible, and the claimed invention does not have a readily apparent well-established utility, reject the claim(s) under § 101 on the grounds that the invention as claimed lacks utility. Also reject the claims under § 112, first paragraph, on the basis that the disclosure fails to teach how to use the invention as claimed.[6]

These guidelines, in my view, are consistent with the holding in Brenner v. Manson that "...a patent is not a hunting license. It is not a reward for the search, but compensation for its successful conclusion."[7]

Do Gene-Related Inventions Satisfy the Enable and Written Description Requirements?

These two separate and distinct requirements are key to the basic constitutional quid pro quo of the patent system. 35 U.S.C. § 112, 1st ¶ states that:

The specification shall contain a written description of the invention...as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same....

With respect to the enablement requirement, there are a number of factors that go into a determination. These include:

Breadth of claims

Nature of the invention

State of the prior art

Level of Skill in the art

Level of predictability

Amount of direction/guidance

Presence/absence of working examples

Quantity of Experimentation

With respect to the written description requirement, the basic question here as in all other fields of technology is:

Can one skilled in the art reasonably conclude that the inventor was in possession of the claimed invention at the time the application was filed?

In general, there is, as there should be, a strong presumption that an adequate written description is present in the application as filed. Thus, the initial burden is on the examiner to establish a prima facie case of unpatentability; however, applicants should be able to show support for new and amended claims.

Factual considerations regarding the written description requirement of gene-related inventions, in view of the level of skill and knowledge in the art, include:

Complete or partial structure

Physical and/or chemical properties

Functional characteristics

Correlation between structure/function

Method of making

Combinations of the above

Since the level of skill and knowledge in any technology increases over time, it follows that the less mature the technology, the more evidence is required to show possession.

Novelty and Nonobviousness

An assertion is sometimes heard that in special cases — with e-commerce and gene-related patents usually being singled out — one should "raise the bar" to prevent "overbroad" patents. This leads to an idea, usually vaguely defined, to change the nonobviousness standard selectively.

Nonobviousness is the most important patentability requirement and perhaps the most difficult to apply. Section 103(a) provides:

A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains.

The enactment of §103 in 1952 was a reaction to a line of Supreme Court cases in which U.S. patents were held to be invalid because they lacked "invention." In one celebrated case, Justice William O. Douglas went so far as to state that for a new device to be patentable, it "must reveal the flash of creative genius." [8] The Supreme Court's anti-patent bias during the period leading up to 1952 was so pronounced that Justice Robert H. Jackson in a dissent complained "that the only patent that is valid is one which this Court has not been able to get its hands on." [9]

In his Commentary on the New Patent Act, Mr. P. J. Federico, a senior official of the U.S. Patent Office and one of the principal authors of the 1952 Act, stated as follows:

There has been some discussion as to whether section 103 modifies the so-called standard of invention (which itself is an unmeasurable quantity having different meanings for different persons) in the courts and it may be correct to state that the printed record does not show an explicit positive command to the courts. While it is not believed that Congress intended any radical change in the level of invention or patentable novelty, nevertheless, it is believed that some modification was intended in the direction of moderating the extreme degrees of strictness exhibited by a number of judicial opinions over the past dozen or more years; that is, that some change of attitude more favorable to patents was hoped for. This is indicated by the language used in section 103 as well as by the general tenor of remarks of the Committees in the reports and particular comments. [10]

The Supreme Court did not reach the issue of the proper interpretation of §103 until 1966, when the Court decided three patent cases, often referred to as the Graham Trilogy.[11] As stated by one leading patent law scholar:

In Graham, the Court pointedly confirmed that Section 103 codified the judicially developed nonobviousness requirement. Congress did focus inquiry on objective obviousness and, in effect, directed abandonment of 'invention,' which the courts had previously used to encapsulate the obviousness standard. 'Invention' had led to conceptual confusion. But, according to the Court, Section 103 did not, and constitutionally could not, 'lower' or fundamentally alter the patentability standard. On the merits, the Court held two of three patents invalid; it held a third patent valid, emphasizing that the invention, a battery that provided strong current with the addition of a water electrolyte, was met with initial skepticism by experts but later was used extensively by the United States government. [12]

In Graham — still the leading case interpreting §103 — the Supreme Court directed the lower courts and the Patent and Trademark Office to apply the following test:

Under § 103, the scope and content of the prior art are to be determined; differences between the prior art and the claims at issue are to be ascertained; and the level of ordinary skill in the pertinent art resolved. Against this background, the obviousness or nonobviousness of the subject matter is determined. Such secondary considerations as commercial success, long felt but unsolved needs, failure of others, etc., might be utilized to give light to the circumstances surrounding the origin of the subject matter sought to be patented. As indicia of obviousness or nonobviousness, these inquiries may have relevancy.

This is not to say, however, that there will not be difficulties in applying the nonobviousness test. What is obvious is not a question upon which there is likely to be uniformity of thought in every given factual context. The difficulties, however, are comparable to those encountered daily by the courts in such frames of reference as negligence and scienter, and should be amenable to a case-by-case development. We believe that strict observance of the requirements laid down here will result in that uniformity and definiteness which Congress called for in the 1952 Act. [13]

Notwithstanding this guidance, the regional Circuit Courts of Appeals were all over the lot in interpreting the requirements of §103. One of the issues was whether "synergism" in some form or another was required to satisfy the §103 requirement. As noted by one patent law scholar, "prior to Federal Circuit analysis of the issue, confusion reigned among lower federal courts as to the proper role of synergism in evaluating nonobviousness." [14]

One of the principal areas of concern that led to the creation of the Federal Circuit was §103 and the differences in its interpretation throughout the regional circuits. Although there are clear differences among the several judges serving on the Court of Appeals for the Federal Circuit in other areas of patent law, there are no major differences in the interpretation of §103. In one celebrated case, the Federal Circuit relied upon §103 when it vacated the Seattle District Court's Preliminary Injunction against BARNESANDNOBLE.COM on February 14, 2001. [15]

Thus, with respect to §103 regarding nonobviousness, three factors have resulted in a workable standard of patentability both in the Patent and Trademark Office and in the courts: (1) the enactment of the section in 1952, (2) the authoritative interpretation of the section in the Graham Trilogy of cases, and (3) the creation of the Federal Circuit, which is doing an excellent job of interpreting §103 on a case-by-case basis. There are now more than 700 Federal Circuit cases interpreting §103 in dozens of technological contexts. If patent claims are said to be "overbroad," I assume that means that they would not be valid under 35 U.S.C. § 103 or § 112, as those sections are now written. Otherwise, I would have no idea what "overbroad" means.

To attempt now to amend § 103 to "raise the bar" — whatever that may mean in a given case — would, at the very least, result in a generation or two of uncertainty and confusion. Such an attempt would, in my view, be met with appropriate, vigorous and successful opposition by high technology industry, inventor groups and the organized patent bar.

* * *

In my remarks today, I have necessarily limited myself to general principles of patent law that are applicable to a consideration of gene-related inventions. Were I still Commissioner of Patents and Trademarks, I would not let electrical engineers anywhere near the examination of applications for patents for gene-related inventions, just as I would not let the USPTO's many Ph.D.s in microbiology or genetics near the examination of complex applications on computer architecture or programming. The same should hold true for attorneys who prosecute patent applications. That is why the U.S. patent system works so well. There can be no discrimination in the system by field of technology — a principle enshrined in Article 27 of the World Trade Organization's Trade-Related Aspects of Intellectual Property ("TRIPS"). But we quite properly depend upon specialists to apply across-the-board general principles to very specialized technological fields of endeavor. This works very well in a system in which in the U.S. "everything under the sun made by humans" is patentable.

[3] 437 U.S. 584 (1978). Parker v. Flook is viewed by many scholars as a curious decision that was overruled by Diamond v. Diehr, 450 U.S. 175 (1981), which provided the legal basis for the thousands of U.S. patents on computer software.

[8]Cuno Engineering Corp. v. Automatic Devices Corp., 314 U.S. 84, 91 (1941). That case specifically prompted Congress to add a sentence to §103 that "Patentability shall not be negatived by the manner in which the invention was made."